Phase 1 Study of MKC-1 in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CASI Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.

• Age greater than or equal to 18 years.

• ECOG performance status ≤1

• ANC greater than or equal to 1,500/mm3;

• Platelets greater than or equal to 100,000/mm3

• creatinine ≤1.5 times institutional upper limit of normal (ULN)

• T Bili within normal limits;

• AST and ALT less than or equal to 2.5 times ULN; and

• albumin greater than or equal to 3.0 g/dL

• have measurable disease by RECIST, radiographically evaluable disease, or detectable disease

• women of child-bearing potential and men must agree to use adequate contraception

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Have previously received MKC-1.

• Have received radiation to greater than 25% of the bone marrow.

• Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

• Are concurrently receiving any other investigational agents while on study.

• Have known brain metastases

• Have any condition that impairs the ability to swallow and retain MKC-1 capsules.

• Uncontrolled intercurrent illness

• Are pregnant or breastfeeding

• HIV-positive patients

• Patients with uncontrolled diabetes